Events

Recall of Device Recall Small Bone Innovations

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Small Bone Innovations.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68445
  • Event Risk Class
    Class 2
  • Event Number
    Z-2127-2014
  • Event Initiated Date
    2014-05-19
  • Event Date Posted
    2014-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127716
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Screw, fixation, bone - Product Code HWC
  • Reason
    Small bone innovations (sbi) is recalling all lots of 3.0/4.0mm autofix" cannulated compression screw system sets, implants, and instruments to update the ifu.
  • Action
    Small Bone Innovations sent an Urgent Medical Device Recall letter, dated May 19, 2014, to all affected customers. The letter that described the product problem, and the action to be taken by the customer. was sent to sales reps, stocking customers, and distributors. Customers were instructed that a copy of the IFU should be stored with each unpackaged AutoFIX 3.0/4.0mm Compression Screw Sets, Implants, or Instruments in their current inventory. Customers were instructed to return all packaged affected product which would be replaced by the firm with an updated IFU. A Federal Express return label was included to facilitate the return shipment. Customers were instructed to complete, sign, and return with the product the Return Material Authorization (RMA) document. For questions regarding this recall call 215-428-1791.

Device

Device Recall Small Bone Innovations
  • Model / Serial
    All lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including TN, OK, AZ, PA, TX, MO, NY, NC, CA, FL, WA, AL, IN, NH, SD, and OH.
  • Product Description
    Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments || Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.
  • Manufacturer
    Small Bone Innovations

Manufacturer

Small Bone Innovations
  • Manufacturer Address
    Small Bone Innovations, 1380 S Pennsylvania Ave, Morrisville PA 19067
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA